EVERETT, Wash.--(SNBL is pleased to announce it has received a response from the U.S. Food and Drug Administration (FDA) regarding the FDA’s September 2011 follow-up and general surveillance inspections. As expected, the inspection results indicate that SNBL USA has remedied all process deficiencies specified in the warning letter.)--
“We attribute this success to several key initiatives that will carry us into the future and strengthen our processes and compliance”
“All remaining reporting requirements will be finished quickly,” said Dr. Thomas Beck, president and COO of SNBL. “We remain confident SNBL is performing at a level that will produce high-quality, GLP-compliant work.”
Specifically, of the nine warning letter items SNBL USA received in August 2010, seven have been completely resolved. The remaining two items require SNBL to finalize several report amendments regarding specific assay issues on certain past studies. SNBL has already made significant progress and plans to finalize all work on these remaining studies quickly.
Fundamental changes occurred at SNBL USA in 2011 that resulted in this positive outcome. SNBL USA conducted thorough GLP trainings for all staff members. SNBL USA, with support from the SNBL Group, has systemically rebuilt the operation and reestablished its ability to provide expertise, value and excellence in preclinical drug development services.
“We attribute this success to several key initiatives that will carry us into the future and strengthen our processes and compliance,” said Beck. These include:
- Top management changes and restructuring
- New directors of pathology, safety assessment and toxicology services, each with years of proven GLP experience
- Expanded QAU Department
- Enhanced training program and documentation
- Comprehensive GLP- and Part 11-compliance training and competency testing
- Additional training for all employees
- New system of continuous QAU training and staff hiring/support
- Master schedule process revisions to monitor reporting timelines appropriately
- Continuous SOP writer training courses to enhance quality of processes
- New dedicated group to schedule & monitor timelines
- Enhanced programs to monitor equipment maintenance and calibration
Moving forward, SNBL USA will continue evaluating and enhancing its systems through the GLP enhancement project, regular facility audits by outside consultants, internal QAU and client audits. The company will also expand its investment in staff training and development.
“Additionally, we will implement a new toxicology data base system, Provantis®, to increase the quality of our reporting and shorten the timeline to finalize studies,” said Beck. “We also will pursue study conduct quality enhancement by implementing scalable process improvements to our current systems.
“We are pleased the recent FDA response reflects the systemic changes and process improvements we have made over the past year. All of us at SNBL USA have worked diligently to reestablish the quality systems and reliable data that made SNBL USA the CRO of choice for primate research,” said Beck.
“Our new VP of Business Development, Mark Crane, has empowered his expanded staff to work with you to meet your drug development needs. Please feel free to contact him or any member of the Business Development team. SNBL USA is looking forward to working with you in the near future to meet your non-clinical development needs,” Beck added.
About SNBL USA, Ltd.
Headquartered in Everett, WA, SNBL USA, Ltd. offers a unique range of safety assessment services to fulfill its commitment of freeing patients from suffering. Managed and operated by a team world renowned for its wide-ranging NHP experience and expertise, it offers programs ranging from regulatory toxicology to customized study designs. Its specialized capabilities include safety assessment of biologics, reproductive toxicology, cardiovascular, respiratory and CNS pharmacology, immunotoxicology and carcinogenicity. SNBL USA’s state-of-the-art facility can house nearly 4,000 NHPs. An available in-house colony ensures a quick study start. Through a commitment to investment and excellence, SNBL USA strives to offer the biotechnology and pharmaceutical industries unparalleled quality in both science and service. For additional information call 425.407.0121 or visit www.snblusa.com.
SNBL USA is a wholly-owned subsidiary of Shin Nippon Biomedical Laboratories, Ltd. (SNBL), one of the largest CROs in Japan. With its multiple worldwide facilities and countless skilled and experienced scientists and technicians SNBL Group works together in providing a full range of drug development services.